DEVICE: Endoform™ Natural Restorative Bioscaffold (09421906017298)
Device Identifier (DI) Information
Endoform™ Natural Restorative Bioscaffold
529304
In Commercial Distribution
AROA BIOSURGERY LIMITED
529304
In Commercial Distribution
AROA BIOSURGERY LIMITED
Endoform™ Natural is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. When rehydrated with wound exudate or sterile saline, Endoform Natural transforms into a soft conforming sheet, which is incorporated into the wound over time.
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45023 | Collagen wound matrix dressing |
A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KGN | Dressing, Wound, Collagen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K092096 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Endoform Natural should be stored at room temperature in a clean and dry area. |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 10 x 12.7 cm - 4 x 5" |
Device Record Status
db29e5a3-40a5-4c69-a78e-8c6c4ac632bf
April 09, 2025
2
August 20, 2021
April 09, 2025
2
August 20, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
09421906017403 | 10 | 09421906017298 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined